• Asian Pacific Journal of Cancer Prevention
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• v.13 no.3
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• pp.979-983
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• 2012

Background : Previous studies have suggested a lack of complete cross-resistance between steroidal (exemestane) and non-steroidal aromatase inhibitors (nSAI). Methods : Eighty-eight metastatic breast cancer (MBC) patients who received 25 mg of exemestane orally once a day at the National Cancer Center, Korea, between 2003 and 2009, were reviewed retrospectively. All patients had received nSAI for metastatic disease prior to exemestane therapy. Results : The median age was 52 years (range, 33-79), and 13 (14.8%) patients were premenopausal who concomitantly received GnRH agonist. Exemestane was given as a second- (80.7%) or third-line (19.3%) hormone therapy. The clinical benefit (CB) rate (complete response + partial response + stable disease ${\geq}$ 24 weeks) was 30.7%, with a median CB duration of 10.0 months (range, 6.3-78.7). The median progression-free survival (PFS) was 3.0 months (95% confidence interval [CI], 1.99-4.01) and the overall survival (OS) 21.5 months (95% CI, 17.96-25.04), with a median followup of 50.3 months. Patients who achieved CB had longer OS than those patients who did not (29.6 vs 17.9 months; P=0.002). On univariate analysis of predictive factors, patients who had achieved CB from previous nSAI tended to show lower CB rate (24.6% vs 44.4%, respectively; P=0.063) and shorter PFS (2.8 vs 4.8 months, respectively; p=0.233) than patients who had not. Achieving CB from previous nSAI became independent predictive factor for CBR to exemestane on multivariable analysis (Odds ratio = 2.852, P = 0.040). Conclusions : Exemestane after nSAI failure was effective in prolonging CB duration. The drug's efficacy seemed to be inferior in patients who had benefit from previous nSAI use.

• Genomics & Informatics
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• v.21 no.3
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• pp.31.1-31.8
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• 2023

Multiple myeloma (MM) is a hematological malignancy. It is widely believed that genetic factors play a significant role in the development of MM, as investigated in numerous studies. However, the application of genomic information for clinical purposes, including diagnostic and prognostic biomarkers, remains largely confined to research. In this study, we utilized genetic information from the Genomic-Driven Clinical Implementation for Multiple Myeloma database, which is dedicated to clinical trial studies on MM. This genetic information was sourced from the genome-wide association studies catalog database. We prioritized genes with the potential to cause MM based on established annotations, as well as biological risk genes for MM, as potential drug target candidates. The DrugBank database was employed to identify drug candidates targeting these genes. Our research led to the discovery of 14 MM biological risk genes and the identification of 10 drugs that target three of these genes. Notably, only one of these 10 drugs, panobinostat, has been approved for use in MM. The two most promising genes, calcium signal-modulating cyclophilin ligand (CAMLG) and histone deacetylase 2 (HDAC2), were targeted by four drugs (cyclosporine, belinostat, vorinostat, and romidepsin), all of which have clinical evidence supporting their use in the treatment of MM. Interestingly, five of the 10 drugs have been approved for other indications than MM, but they may also be effective in treating MM. Therefore, this study aimed to clarify the genomic variants involved in the pathogenesis of MM and highlight the potential benefits of these genomic variants in drug discovery.

• The Korean journal of internal medicine
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• v.39 no.1
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• pp.172-183
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• 2024

Background/Aims: This study aimed to identify the clinical characteristics of patients with concurrent rheumatoid arthritis (RA) and suspected non-tuberculous mycobacterial (NTM) infections as well as determine their prognostic factors. Methods: We retrospectively reviewed the medical records of 91 patients with RA whose computed tomography (CT) findings suggested NTM infection. Subsequently, we compared the clinical characteristics between patients with and without clinical or radiological exacerbation of NTM-pulmonary disease (PD) and investigated the risk factors for the exacerbation and associated mortality. Results: The mean age of patients with RA and suspected NTM-PD was 65.0 ± 10.2 years. The nodular/bronchiectatic (NB) form of NTM-PD was the predominant radiographic feature (78.0%). During follow-up, 36 patients (41.9%) experienced a radiological or clinical exacerbation of NTM-PD, whereas 12 patients (13.2%) died. Combined interstitial lung disease (ILD), microbiologically confirmed NTM-PD, and NB with the fibrocavitary (FC) form on chest CT were identified as risk factors for the clinical or radiological exacerbation of NTM-PD. Hydroxychloroquine use was identified as a good prognostic factor. Conversely, history of tuberculosis, ILD, smoking, microbiologically confirmed NTM-PD, and NB with the FC form on chest CT were identified as poor prognostic factors for mortality in suspected NTM-PD. Conclusions: ILD and NB with the FC form on chest CT were associated with NTM-PD exacerbation and mortality. Hydroxychloroquine use may lower the risk of NTM-PD exacerbation. Therefore, radiographic features and presence of ILD should be considered when predicting the prognosis of patients with RA and suspected NTM-PD.

• Korean Journal of Clinical Pharmacy
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• v.11 no.1
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• pp.30-41
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• 2001

Recently, the use of electronic drug information databases has been increased alternative to printed references. However, databases vary widely in quality and quantity of drug information provided and many questions have arisen about their accuracy, completeness, and reliability. This study was designed to compare and evaluate the drug information contained in four Korean drug information databases which are available on CD-ROM and internet. Four Korean drug information databases selected to be evaluated were eKIMS, Datapower, KPA Standard Drug Information and Korean Drug Formulary. Databases were searched and evaluated from August 10 to September 30, 2000 by the same trained searcher to minimize the bias. The database evaluation form was developed for objective evaluation of each databases in terms of credibility of database, convenience of use and other characteristics. The second form was developed for quantitative and qualitative assessment of the drug information provided by the databases. The results of the study showed that there were no significant differences in 4 databases in terms of convenience of use and other characteristics. However, for credibility of databases, Korean Drug Formulary was significantly superior to all other databases (P<0.05). It showed that information provided by Korean Drug Formulary was the best in terms of pharmacokinetics, chemistry, comparisons and eKIMS was the best in terms of drug identification (P<0.05). For accuracy and completeness of information provided, the study could not find a significant difference between 4 databases (P>0.05).

• Korean Journal of Clinical Pharmacy
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• v.30 no.2
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• pp.120-126
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• 2020

Objective: The rising number of carbapenemase-resistant Enterobacteriaceae (CRE) cases has become a concern worldwidely. This study investigated patient characteristics with CRE and analyzed the risk factors associated with its acquisition. Methods: A retrospective review of the electronic medical records of the Kangbuk Samsung Medical Center from May 2016 to April 2019 was performed. The inclusion criterion was hospitalized patients aged ≥18 years with confirmed CRE acquisition. Patients were divided by CRE acquired and non-required patients. CRE acquired patients were those with CRE confirmed by their active surveillance cultures, while non-acquired patients were those with carbapenemase-sensitive Enterobacteriaceae (CSE). If CRE was isolated more than once during hospitalization, only the first isolation was used for data analysis. Patient characteristics, antibiotic used, and the duration of use were compared between two groups using univariate analysis, and the risk factors associated with CRE were analyzed using multiple logistic regression analysis. Results: Among the 73 CRE acquired patients, 44 (60.3%) were positive for carbapenemase-producing Enterobacteriaceae (CPE). Infection from Klebsiella pneumonia (42 cases, 57.5%), Escherichia coli (17 cases, 23.3%), and Enterobacter cloacae (5 cases, 6.8%). The risk of CRE acquisition was significantly increased by 4.99 times [confidence interval (CI), 1.40-17.78; p=0.013] with mechanical ventilation, 3.86 times (CI, 1.59-9.36; p=0.003) with penicillin administration, and 21.19 times (CI, 6.53-68.70; p<0.001) with carbapenem administration. Conclusions: Proper antibiotic use including the selection, frequency, and duration, and patients on mechanical ventilators need close monitoring.

• Asian Pacific Journal of Cancer Prevention
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• v.15 no.4
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• pp.1707-1710
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• 2014

Background: The objective of this study was to evaluate baseline use and positive rates of staging images (bone scan, CT) in newly diagnosed patients with prostate cancer (PCa) and to improve staging image overuse. Materials and Methods: This retrospective study covered a consecutive series of patients with PCa who underwent stage imaging at our institution between 2006 and 2011. Various clinical and pathological variables (age, PSA, biopsy Gleason score, clinical T stage, positive biopsy core rate) were evaluated by multivariate logistic regression analysis for their ability to predict a positive staging image. All patients were stratified according to the NCCN risk stratification and positive rates were compared in each risk group. Results: 410 patients (100%) underwent a bone scan and 315 patients (76.8%) underwent a CT scan. Some 51 patients (12.4%) had a positive bone scan, clinical T3 and T4 being significant independent predictors. Positive bone scan rates for low-, intermediate-, high-, and very high-risk groups were 0%, 0%, 8.25%, and 56.6%. Some 59 (18.7%) patients had a positive CT scan, with elevated PSA and clinical T3, T4 as significant independent predictors. Low-, intermediate-, high- and very high-risk group rates were 0%, 0%, 13.8% and 80.0%. Conclusions: The incidences of positive staging image in low- and intermediate- risk group were reasonably low. Following feedback on these results, staging in low- and intermediate- risk groups could be omitted.

• The Journal of Internal Korean Medicine
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• v.40 no.6
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• pp.1015-1025
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• 2019

Objectives: There have been many studies reporting the clinical value of Euphorbia kansui Radix or Melonis Calyx, but few systematic studies of the changes that may occur after taking such herbal medication. This study aimed to investigate the characteristics of the patient group, possible changes in blood test and InBody test results, and to discover the current state and future direction of clinical use of Euphorbia kansui Radix or Melonis Calyx. Methods: This study investigated patients who were hospitalized at Kyung-Hee University Korean Medicine Hospital for at least two days from 1 March 2016 to 1 March 2019, specifically evaluating patients aged 19 and over who underwent blood tests, including an electrolyte test and an InBody test before and after taking Euphorbia kansui Radix or Melonis Calyx. Results: Among a total of 134 patients, 72 patients (53.7%) were treated with Euphorbia kansui Radix and 62 patients (46.3%) were treated with Melonis Calyx, in the context of previously diagnosed abnormal weight gain. Laboratory findings were that Na and K levels were significantly reduced in both groups. In an InBody test, body mass index (BMI), intracellular water, extracellular water, protein, mineral, and skeletal muscle were significantly reduced in both groups. Conclusions: From these results, we suggest that, although Euphorbia kansui Radix and Melonis Calyx may not induce serious adverse effects, attention should be paid to the electrolyte level with the use of these treatments. In terms of syndrome differentiation, more clinical uses will be available in the future.

• Journal of Korean Medical Ki-Gong Academy
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• v.13 no.1
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• pp.77-104
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• 2013

In this study we examined the concerned literature for clinical use of Balsaminaceae plants focusing on the latest literature "zhong hua ben cao"(chinese materia medica, 1998). The findings were summarized as follows: 1. As an original plant, 27 species have been reviewed. 2. As a result of investigating oriental drug names by medicinal using part, a survey reported that the total of 22 species of oriental drug names, including 14 species of herba, 3 species of flos, 4 species of radix and rhizoma, and 1 species of semen, are being used for clinical use. 3. When we examined oriental drugs with five flavors by calculating and arranging their nature, effect, toxicity with points for conveniences sake, pungent and bitte showed 13 points, respectively, as main flavors. In drug nature, warm property of drug indicated 10 points and cold property of drug obtained 6 points. But as for other oriental drug, it is thought that we can recognize their significance. 4. With respect to efficacy, activating blood drug reached 10 kinds and wind- damp-dispelling 7 kinds, according to the examination. 5. In the examination on components and medicinal action, we examined that components are recorded in only impatiens balsamina's whole grass, flowers, root, root stems, and seeds, and Impatiens noli-tangere's whole grass. In medical action, we found out that the components are recorded in impatiens balsamina' flowers and seeds; impatiens noli-tangere's whole grass and flowers; and Impatiens textori' whole grass. 6. As a result of examining clinical prescription, the total of 84 kinds of clinical prescriptions by disease nature were examined, of which the prescription of Impatiens balsamina showed 19 cases in total, which was remarkable.

• Herbal Formula Science
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• v.17 no.2
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• pp.111-121
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• 2009

Objectives : This study was performed to evaluate the efficacy of ampule containing herbal extract(Ulmus davidiana, Ginkgo biloba, Perilla ocymoides, Morus alba, Glycyrrhiza uralensis (licorice), and Angelica gigas) on skin wrinkles in adult women with facial wrinkles. Methods : A total of 12 women, 30 to 46 years of age, with wrinkles in the corner of eyes, applied ampule containing herbal extract twice daily for up to 12 weeks. Silicon replicas of right crow's feet area and antecubital fossa were taken before use of test product and at 4, 8 and 12 weeks. The replicas were analyzed by optical profilometry with Skin Visiometer SV600. The wrinkle and roughness parameters, R1, R2, R3, R4 and R5 were calculated and statistically analyzed. In addition, a subjective evaluation of product efficacy was conducted by patient's assessment. Results : The mean values of all the skin roughness parameters were decreased at 4-week, and decreased significantly at 8 and 12-week except R4 at 12-week after test product use. The subjective evaluation of wrinkle by patient's assessment was also improved. However, one patient noted stiffness of face after use of test product. Conclusions : These study suggested that the application of ampule containing herbal extract twice daily for 12 weeks may effectively improve the facial wrinkles without severe side effect.

• Communications for Statistical Applications and Methods
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• v.25 no.4
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• pp.341-354
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• 2018

The one of the principles described in ICH E9 is that only results obtained from pre-specified statistical methods in a protocol are regarded as confirmatory evidence. However, in multi-regional clinical trials, even when results obtained from pre-specified statistical methods in protocol are significant, it does not guarantee that the test treatment is approved by regional regulatory agencies. In other words, there is no so-called global approval, and each regional regulatory agency makes its own decision in the face of the same set of data from a multi-regional clinical trial. Under this situation, there are two natural methods a regional regulatory agency can use to estimate the treatment effect in a particular region. The first method is to use the overall treatment estimate, which is to extrapolate the overall result to the region of interest. The second method is to use regional treatment estimate. If the treatment effect is completely identical across all regions, it is obvious that the overall treatment estimator is more efficient than the regional treatment estimator. However, it is not possible to confirm statistically that the treatment effect is completely identical in all regions. Furthermore, some magnitude of regional differences within the range of clinical relevance may naturally exist for various reasons due to, for instance, intrinsic and extrinsic factors. Nevertheless, if the magnitude of regional differences is relatively small, a conventional method to estimate the treatment effect in the region of interest is to extrapolate the overall result to that region. The purpose of this paper is to investigate the effects produced by this type of extrapolation via estimations, followed by hypothesis testing of the treatment effect in the region of interest. This paper is written from the viewpoint of regional regulatory agencies.